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Testing Doxazosin to Treat Stress Mechanisms in Alcoholism

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ClinicalTrials.gov Identifier: NCT02989493
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
Double-blind, placebo controlled, randomized controlled trial (RCT) for Alcohol Use Disorder examining the effects of doxazosin, a norepinephrine alpha1 receptor antagonist, on stress reactivity and clinical outcomes.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Doxazosin Other: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Targeting Noradrenergic Stress Mechanisms in Alcoholism With Doxazosin
Actual Study Start Date : April 12, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Doxazosin
Participants receive 8 weeks of doxazosin (8mg target dose).
Drug: Doxazosin
Doxazosin

Placebo Comparator: Placebo
Participants will receive 8 weeks of matched placebo.
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Startle potentiation during stress reactivity task [ Time Frame: 4 weeks ]
    Startle potentiation is measured in the NPU task

  2. No heavy drinking days [ Time Frame: 8 weeks ]
    Scored yes or no to indicate if participant reported any days of heavy drinking (> 4/3 standard drinks for men/women) during the 8 week assessment period

  3. Total number of alcoholic drinks [ Time Frame: 8 weeks ]
    Total number of alcoholic drinks consumed during the 8 week assessment period

  4. Total number of drinking days [ Time Frame: 8 weeks ]
    Total number of days that alcohol was consumed during the 8 week assessment period


Secondary Outcome Measures :
  1. Self-reported anxiety during stress reactivity task [ Time Frame: 4 weeks ]
    Self reported anxiety is measured in response to the stressors in the NPU task



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Diagnostic and Statistical Manual (DSM-5) diagnosis of Alcohol Use Disorder, Moderate-Severe
  • Alcohol abstinent for 1 - 8 weeks
  • Ages of 18 to 65

Exclusion criteria are divided into three broad categories of Medical, Psychiatric/Behavioral, and Medications/Therapies.

EXCLUSION CRITERIA: Medical

  • Blood alcohol concentration above 0.00.
  • Color blind.
  • Heart rate >100 beats per minute after five minutes seated.
  • Heart rate <55 beats per minute after five minutes seated.
  • Systolic BP <100 after five minutes seated.
  • Systolic BP drop >20mm Hg or diastolic BP drop >10mm Hg after two minutes standing.
  • Dizziness, lightheadedness, unsteadiness or other problems (e.g, nausea, blurry vision) after two minutes standing.
  • Uncorrected auditory/vision problems.
  • Current treatment for chronic pain condition.
  • Past or current coronary artery disease, cerebrovascular accident, congestive heart failure.
  • Current chronic renal insufficiency, liver insufficiency or moderate hepatic impairment, pancreatitis, immunosuppressive therapy, or cancer with systemic effects or therapy.
  • Benign positional vertigo, Meniere's disease, or narcolepsy.
  • Previous allergic or adverse reaction to doxazosin or other alpha1 noradrenergic antagonist.
  • Scheduled or reported plans for cataract surgery prior to study completion.
  • Currently symptomatic of alcohol withdrawal [Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) Score > 10, or positive for any 'visual, auditory or tactile disturbances,' or for 'orientation and clouding of sensorium']
  • Discharged from inpatient treatment for Alcohol Use Disorder or alcohol detoxification within past 7 days.
  • Currently medically unstable.
  • Electrocardiogram (ECG) clinical over-read indicates concerns of cardiac function.
  • Other self-reported acute or unstable illness that, in the opinion of the study team, would preclude a safe and reliable study participation

EXCLUSION CRITERIA: Female Participants Only

  • Non-negative urine pregnancy test.
  • Women of childbearing potential (see definition below) must agree to use one of the following forms of birth control until after study completion. Acceptable birth control is defined as the following methods of contraception: abstinence; hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy of partner and tubal ligation; "single" barrier methods of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge) with use of spermicide; or "double barrier" method of contraception (e.g. male condom with diaphragm, male condom with cervical cap).
  • Breastfeeding.

NOTE: Women of childbearing potential are females who have experienced menarche and do not meet the criteria for women not of childbearing potential. Women not of childbearing potential are females who are permanently sterile (e.g., hysterectomy, bilateral oophorectomy) or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

EXCLUSION CRITERIA: Psychological/Behavioral

  • Self-reported lifetime diagnosis of schizophrenia, schizoaffective disorder, psychotic disorder not otherwise specified, bipolar disorder (with manic episode), borderline personality disorder, or any neurocognitive disorder that may impair a reliable, safe participation.
  • Current suicidal ideation.
  • Current active substance use disorder other than alcohol or tobacco.

EXCLUSION CRITERIA: Medications/Therapies

  • Currently prescribed or used within past week: doxazosin or other alpha1 noradrenergic antagonist (e.g., prazosin, terazosin).
  • Currently prescribed or used within past week: substances with stimulant properties (e.g., d-amphetamine, methylphenidate, ephedra, pseudoephedrine).
  • Currently prescribed or used within past week: Sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra).
  • Currently prescribed or used within past week: beta-blockers (e.g., propanolol), alpha2 agonists (e.g., clonidine, guanfacine, dexmedetomidine), and serotonin and norepinephrine reuptake inhibitors (SNRI) (e.g., venlafaxine, duloxetine, atomoxetine, viloxazine).
  • Currently used daily or used within past week: alpha1 agonists (e.g., midodrine, metaraminol, oxymetazoline, phenylephrine).
  • Currently used daily or used within past week: Benzodiazepines (e.g., diazepam, chlordiazepoxide, lorazepam, clonazepam, alprazolam), zolpidem (Ambien), zaleplon (Sonata), zopiclone (Imovane), eszopiclone (Lunesta), doxepin (Silenor).
  • Currently prescribed and used daily or used within past 2 weeks: Trazodone.
  • Currently prescribed or used within 2 weeks: Disulfiram (Antabuse).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989493


Contacts
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Contact: John J Curtin, PhD 608-262-0387 jjcurtin@wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53706
Contact: John J Curtin, PhD    608-262-0387    jjcurtin@wisc.edu   
Principal Investigator: John J Curtin, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: John J Curtin, PhD University of Wisconsin, Madison

Additional Information:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02989493     History of Changes
Other Study ID Numbers: Dox
R01AA024388 ( U.S. NIH Grant/Contract )
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available online upon study completion at the Open Science Framework: https://osf.io

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Wisconsin, Madison:
Alcoholism
Stress
Norepinephrine
Doxazosin
Anxiety
Startle Potentiation
Relapse
Adrenergic Antagonists
Surrogate Endpoint

Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Doxazosin
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs